(113 days)
No
The description focuses on image-guided surgery, spatial mapping, and real-time visualization, which are standard features of image-guided surgery systems and do not inherently require AI/ML. There is no mention of AI, DNN, or ML in the provided text, nor are there descriptions of training or test sets typically associated with AI/ML development.
No.
The document states that the device is for "treatment planning and intra-operative guidance for surgical procedures" and "guides a surgical instrument to a target". It does not directly provide therapy or treatment.
No
The device is described as an image-guided surgery system intended for treatment planning and intra-operative guidance for surgical procedures, focusing on real-time visualization and navigation tools rather than diagnosing disease.
No
The device description explicitly states it is a "computer assisted, image guided surgery system" that "guides a surgical instrument to a target". This implies the system includes hardware components for tracking and guiding the instrument, in addition to the software for visualization and navigation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ABARIS Function: The ABARIS system is an image-guided surgery system. Its primary function is to assist physicians in planning and navigating surgical procedures by displaying and tracking surgical instruments in relation to patient anatomy using various imaging modalities. It does not analyze biological specimens.
The device's intended use, device description, and the types of inputs (imaging modalities) all point to it being a surgical guidance system, not an IVD.
N/A
Intended Use / Indications for Use
ABARIS is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance, (MR), Ultrasound (US), Position Emission Tomography (PET), Single Photon Prosonan Computed Tomography (SPECT), Fluoroscopy, Endoscopy and other imaging systems. It displays the simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target psy noeans, guidewire and the projected future path of the interventional instrument taking into account movements of the patient. This is intended for treatment planning and intra-onerative guidant for surgical procedures. The device also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device.
The device is intended to be used in clinical interventions and for anatomical structures where imaging is currently used for visualizing such procedures. The device is also intended for use in clinical interventions to determine the proximity of one device relative to ano inchier.
Product codes
JAK
Device Description
The ABARIS is a computer assisted, image guided surgery system. It guides a surgical instrument to a target that has been defined by the physician. The target can be indicated either preoperatively or intraoperatively using images or relative to an indicated position on the patient.
The ABARIS provides real-time, three-dimensional visualization and navigation tools for all stages of surgery including preoperative planning and intra-operative navigation. ABARIS transforms two-dimensional patient images (scan sets), derived from Computed Tomography (CT), Magnetic Resonance Imaging (MR), Position Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Ultrasound (US), Fluoroscopy etc. into dynamic representations on which a tool can be navigated. The system performs spatial mapping from one inage space to another image space or from image space to physical space ("vegistation") allowing the physician to correlate scan sets with each other and to the patient The system facilitates minimally invasive surgical procedures. Like other commercially available image guided surgery systems, the ABARIS also offers computer assisted image-free and registration free navigation using the same instrumentation.
Targeted use areas for ABARIS include hospital operating rooms, outpatient surgery centers and procedure rooms.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), Magnetic Resonance Imaging (MR), Position Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Ultrasound (US), Fluoroscopy
Anatomical Site
anatomical structures where imaging is currently used for visualizing such procedures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician / hospital operating rooms, outpatient surgery centers and procedure rooms.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K050438, K043088, K030552, K030106, K022126, K021980, K022414, K020338, K012937, K003201, K001284, K992461, K992927, K990214, K983670, K983397, K981768, K981686, K981684, K974187, K974161, K972398, K963173, K954276
Reference Device(s)
K023227, K022354, K013150, K011418, K002258, K974432, K000171, K012886, K960330, K981998, K982994, K983529, K994270, K003510, K040050
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
510(k) Summary of Safety and Effectiveness for ABARIS
I. Manufacturer Traxtal Technologies Inc. 49 Spadina Ave. Suite 402C Toronto, Ontario Canada M5V2J1
APR 1 9 2006
II. Contact Person Dr. Neil Glossop, President Traxtal Technologies Inc. Tel: 416-603-8349 Fax: 416-603-8354
III. Product Name/Classification Name Product Name: ABARIS Common Name: Computer assisted, image-guided surgery system Classification Name: Computed Tomography X-ray System Class II as described in 21 CFR 892.1750 Product Code: JAK
- IV. Date Prepared December 19, 2005.
1
V. Device Description
The ABARIS is a computer assisted, image guided surgery system. It guides a surgical instrument to a target that has been defined by the physician. The target can be indicated either preoperatively or intraoperatively using images or relative to an indicated position on the patient.
The ABARIS provides real-time, three-dimensional visualization and navigation tools for all stages of surgery including preoperative planning and intra-operative navigation. ABARIS transforms two-dimensional patient images (scan sets), derived from Computed Tomography (CT), Magnetic Resonance Imaging (MR), Position Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Ultrasound (US), Fluoroscopy etc. into dynamic representations on which a tool can be navigated. The system performs spatial mapping from one inage space to another image space or from image space to physical space ("vegistation") allowing the physician to correlate scan sets with each other and to the patient The system facilitates minimally invasive surgical procedures. Like other commercially available image guided surgery systems, the ABARIS also offers computer assisted image-free and registration free navigation using the same instrumentation.
Targeted use areas for ABARIS include hospital operating rooms, outpatient surgery centers and procedure rooms.
VI. Intended Use
ABARIS is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance, (MR), Ultrasound (US), Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Fluoroscopy, Endoscopy and other imaging systems. It displays the simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organs and the current and the projected future pattent that interventional instrument taking into account movements of the patient. This is intended for treatment planning and intra-operative guidance for surgical procedures. The device also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device.
The device is intended to be used in clinical interventions and for anatomical structures where imaging is currently used for visualizing such procedures. The device is also intended for use in clinical interventions to determine the proximity of one device relative to another.
2
VII. Substantial Equivalence
The technological characteristics of the ABARIS are the same or similar to those found in the predicate devices. The ABARIS is substantially equivalent to the following four FDA cleared frameless stereotaxic systems:
| System Name | Manufacturer | 510(k) approval
number |
|------------------------------------|-------------------------------------------------------|---------------------------------------------------------------------------------|
| Ultraguide | Ultraguide Ltd. | K023227, K022354,
K013150, K011418,
K002258, K974432 |
| StealthStation System | Medtronic Navigation,
Inc. | K050438, K043088, |
| | | K030552, K030106, |
| | | K022126, K021980, |
| | | K022414, K020338, |
| | | K012937, K003201, |
| | | K001284, K992461, |
| | | K992927, K990214, |
| | | K983670, K983397, |
| | | K981768, K981686,
K981684, K974187,
K974161, K972398,
K963173, K954276 |
| CBYON Surgical Operating
System | Cbyon, Inc. | K000171, K012886 |
| Instatrak | GE Medical Systems
Navigation and
Visualization | K960330, K981998, |
| | | K982994, K983529, |
| | | K994270,K003510,
K040050 |
The device labeling contains instructions for use. It includes indications for use, cautions, contraindications, warnings, and planning guidance. This information assures safe and effective use of the device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 1 9 2006
Neil Glossop, Ph.D. President Traxtal Technologies 49 Spadina Avenue, Suite 402C Toronto, Ontario, M5V 2J1 CANADA
Re: K053610
Trade/Device Name: ABARIS Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 24, 2006 Reccived: March 27, 2006
Dear Dr. Glossop:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/3/Picture/10 description: The image shows a circular logo with the letters "FDA" in bold, black font. Above the letters, the numbers "1906 - 2006" are printed. Below the letters, the word "Centennial" is printed in a smaller font. The logo is surrounded by text that reads "Protecting and Promoting Public". The logo appears to be a commemorative emblem for the FDA's centennial anniversary.
4
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premaincel notificated with a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rr you a the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 Also, prease not the regarial information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
| Applicant: | Traxtal Technologies Inc. |
|---|---|
| 510(k) Number (if known): | Not yet assigned K053610 |
| Device Name: | ABARIS |
Indications for Use:
ABARIS is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance, (MR), Ultrasound (US), Position Emission Tomography (PET), Single Photon Prosonan Computed Tomography (SPECT), Fluoroscopy, Endoscopy and other imaging systems. It displays the simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target psy noeans, guidewire and the projected future path of the interventional instrument taking into account movements of the patient. This is intended for treatment planning and intra-onerative guidant for surgical procedures. The device also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device.
The device is intended to be used in clinical interventions and for anatomical structures where imaging is currently used for visualizing such procedures. The device is also intended for use in clinical interventions to determine the proximity of one device relative to ano inchier.
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use
| (Per 21 CFR 801 Subpart D) |
|---|
| ------------------------------------------------ |
| OR |
|---|
| ---- |
| Over-The-Counter Use
| (Per 21 CFR 807 Subpart D) |
|---|
| ---------------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
David A. Sepponen
Division of Reproductive, and Radiological Devic 510(k) Numb